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QRxPharma Receives Positive Feedback from Scientific Advice Meetings in Europe on MoxDuo®IR Development and Registration
Date:7/26/2010

BEDMINSTER, N.J. and SYDNEY, July 26 /PRNewswire-FirstCall/ -- QRxPharma (ASX: QRX and Pink Sheets: QRXPY) reported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid™ pain therapy. The Company is currently completing pivotal Phase 3 trials required for filing a New Drug Application (NDA) for MoxDuo IR with the United States Food and Drug Administration (FDA). QRxPharma intends to submit a Marketing Authorisation Application (MAA) in Europe, the second largest market (approximately US$3.5 billion) in the world for opioid analgesics. In support of these registration activities, the Company held Scientific Advice meetings in Germany and the United Kingdom in May 2010. Based on the positive responses in the official minutes of these meetings, QRxPharma intends to select Germany as the lead Agency for European MAA review, and will submit the application in 2011.

"Similar to the FDA's acceptance of our streamlined development plan for MoxDuo IR, feedback and guidance from the European Agencies regarding the suitability of our data package for MAA submission is also positive," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "Our objective is to launch MoxDuo IR globally in 2012, and this feedback clears a significant hurdle and facilitates our European regulatory and commercialisation strategy."

In reply to questions posed by QRxPharma to the German Federal Institute for Drugs and Medical Devices (BfArM), the data package available from the U
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